
Sil-Med Corp.
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TENCKHOFF CATHETER is an FDA 510(k)-cleared medical device (K801818) manufactured by Sil-Med Corp.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 22, 1980. Regulation: 8.